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NCT05067634

Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

StatusCompleted
PhasePhase 3
Primary completion
Track this trial

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Record History

The 50 most recent of 55 versions: 47 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 154 participants (planned 140)
    • Primary completion date changed from estimate of Nov 2026 to Oct 2, 2026
    • Eligibility criteria expanded, about 36 words
    • Site details revised at 10 of 35 sites
  2. Start date: Jan 14, 2022 to Jan 10, 2022v54
  3. Trial sites reduced: 54 → 35 locationsv53
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 55 to 54
    • Primary and study completion dates pushed to Nov 2026
    v51
  5. Site details revised at 2 of 55 sitesv50
Show 42 earlier versionsHide 42 earlier versions
  1. Site details revised at 2 of 55 sitesv49
  2. Site contacts updated at 2 of 55 sitesv48
  3. Site details revised at 1 of 55 sitesv47
  4. Study sites: 54 to 55v46
  5. Study sites: 53 to 54v45
  6. Study sites: 52 to 53v44
  7. Study sites: 51 to 52v43
  8. Study sites: 50 to 51v42
  9. Study sites: 49 to 50v41
  10. Study sites: 48 to 49v40
  11. Study sites: 47 to 48v39
  12. Study sites: 46 to 47v38
  13. Study sites: 45 to 46v37
  14. Study sites: 44 to 45v36
  15. Study sites: 43 to 44v35
  16. Study sites: 40 to 43v33
  17. Site contacts updated at 1 of 40 sitesv32
  18. Study sites: 39 to 40v31
  19. Study sites: 38 to 39v30
  20. Study sites: 37 to 38v29
  21. Study sites: 36 to 37v28
  22. Study sites: 34 to 36v27
  23. Study sites: 33 to 34v26
  24. Study sites: 32 to 33v25
  25. Study sites: 29 to 32v24
  26. Study sites: 28 to 29v23
  27. Study sites: 27 to 28v22
  28. Study sites: 26 to 27v21
  29. Study sites: 21 to 26v20
  30. Study sites: 17 to 21v19
  31. Study sites: 15 to 17v18
  32. Study sites: 13 to 15v17
  33. Study sites: 11 to 13v16
  34. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 11 of 11 sites
    v15
  35. Study sites: 9 to 11v14
  36. Study sites: 8 to 9v13
  37. Study sites: 7 to 8v12
  38. Study sites: 6 to 7v11
  39. Study sites: 5 to 6v10
  40. Primary completion date: Sep 2024 to May 2026
    • Study completion date: Sep 2024 to Jul 2026
    v9
  41. Study sites: 3 to 5v7
  42. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 3
    v6
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of Adverse Events and SAEs
Timeframe: 3 Years

Secondary (2)

To collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures
Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and tablets

Arms and interventions

12 to < 18 year oldsExperimental
6 to <12 years oldExperimental
4 to <6 years oldExperimental
2 to <4 years oldExperimental

Drugs: Xcopri

Sites

35 sites in 7 countries

United States 14, South Korea 6, Hungary 4, Spain 4, Australia 3, Poland 3, Germany 1